EP2925258B1 - Élément endoprothétique - Google Patents

Élément endoprothétique Download PDF

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Publication number
EP2925258B1
EP2925258B1 EP13795250.3A EP13795250A EP2925258B1 EP 2925258 B1 EP2925258 B1 EP 2925258B1 EP 13795250 A EP13795250 A EP 13795250A EP 2925258 B1 EP2925258 B1 EP 2925258B1
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EP
European Patent Office
Prior art keywords
region
component according
endoprosthetic
endoprosthetic component
component
Prior art date
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Application number
EP13795250.3A
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German (de)
English (en)
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EP2925258A2 (fr
Inventor
Alfons Kelnberger
Heinrich Wecker
Frank Ziermann
Mateusz Juszczyk
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Ceramtec GmbH
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Ceramtec GmbH
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Publication of EP2925258A2 publication Critical patent/EP2925258A2/fr
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    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
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    • C04B35/48—Shaped ceramic products characterised by their composition; Ceramics compositions; Processing powders of inorganic compounds preparatory to the manufacturing of ceramic products based on oxide ceramics based on zirconium or hafnium oxides, zirconates, zircon or hafnates
    • C—CHEMISTRY; METALLURGY
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    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/10—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing inorganic materials
    • A61L2300/112—Phosphorus-containing compounds, e.g. phosphates, phosphonates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2430/00—Materials or treatment for tissue regeneration
    • A61L2430/38—Materials or treatment for tissue regeneration for reconstruction of the spine, vertebrae or intervertebral discs
    • C—CHEMISTRY; METALLURGY
    • C04—CEMENTS; CONCRETE; ARTIFICIAL STONE; CERAMICS; REFRACTORIES
    • C04B—LIME, MAGNESIA; SLAG; CEMENTS; COMPOSITIONS THEREOF, e.g. MORTARS, CONCRETE OR LIKE BUILDING MATERIALS; ARTIFICIAL STONE; CERAMICS; REFRACTORIES; TREATMENT OF NATURAL STONE
    • C04B2111/00—Mortars, concrete or artificial stone or mixtures to prepare them, characterised by specific function, property or use
    • C04B2111/00474—Uses not provided for elsewhere in C04B2111/00
    • C04B2111/00836—Uses not provided for elsewhere in C04B2111/00 for medical or dental applications
    • C—CHEMISTRY; METALLURGY
    • C04—CEMENTS; CONCRETE; ARTIFICIAL STONE; CERAMICS; REFRACTORIES
    • C04B—LIME, MAGNESIA; SLAG; CEMENTS; COMPOSITIONS THEREOF, e.g. MORTARS, CONCRETE OR LIKE BUILDING MATERIALS; ARTIFICIAL STONE; CERAMICS; REFRACTORIES; TREATMENT OF NATURAL STONE
    • C04B2235/00—Aspects relating to ceramic starting mixtures or sintered ceramic products
    • C04B2235/02—Composition of constituents of the starting material or of secondary phases of the final product
    • C04B2235/30—Constituents and secondary phases not being of a fibrous nature
    • C04B2235/32—Metal oxides, mixed metal oxides, or oxide-forming salts thereof, e.g. carbonates, nitrates, (oxy)hydroxides, chlorides
    • C04B2235/3217—Aluminum oxide or oxide forming salts thereof, e.g. bauxite, alpha-alumina
    • C—CHEMISTRY; METALLURGY
    • C04—CEMENTS; CONCRETE; ARTIFICIAL STONE; CERAMICS; REFRACTORIES
    • C04B—LIME, MAGNESIA; SLAG; CEMENTS; COMPOSITIONS THEREOF, e.g. MORTARS, CONCRETE OR LIKE BUILDING MATERIALS; ARTIFICIAL STONE; CERAMICS; REFRACTORIES; TREATMENT OF NATURAL STONE
    • C04B2235/00—Aspects relating to ceramic starting mixtures or sintered ceramic products
    • C04B2235/02—Composition of constituents of the starting material or of secondary phases of the final product
    • C04B2235/30—Constituents and secondary phases not being of a fibrous nature
    • C04B2235/32—Metal oxides, mixed metal oxides, or oxide-forming salts thereof, e.g. carbonates, nitrates, (oxy)hydroxides, chlorides
    • C04B2235/3231—Refractory metal oxides, their mixed metal oxides, or oxide-forming salts thereof
    • C04B2235/3244—Zirconium oxides, zirconates, hafnium oxides, hafnates, or oxide-forming salts thereof
    • C—CHEMISTRY; METALLURGY
    • C04—CEMENTS; CONCRETE; ARTIFICIAL STONE; CERAMICS; REFRACTORIES
    • C04B—LIME, MAGNESIA; SLAG; CEMENTS; COMPOSITIONS THEREOF, e.g. MORTARS, CONCRETE OR LIKE BUILDING MATERIALS; ARTIFICIAL STONE; CERAMICS; REFRACTORIES; TREATMENT OF NATURAL STONE
    • C04B2235/00—Aspects relating to ceramic starting mixtures or sintered ceramic products
    • C04B2235/02—Composition of constituents of the starting material or of secondary phases of the final product
    • C04B2235/30—Constituents and secondary phases not being of a fibrous nature
    • C04B2235/32—Metal oxides, mixed metal oxides, or oxide-forming salts thereof, e.g. carbonates, nitrates, (oxy)hydroxides, chlorides
    • C04B2235/3231—Refractory metal oxides, their mixed metal oxides, or oxide-forming salts thereof
    • C04B2235/3244—Zirconium oxides, zirconates, hafnium oxides, hafnates, or oxide-forming salts thereof
    • C04B2235/3246—Stabilised zirconias, e.g. YSZ or cerium stabilised zirconia
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T428/00—Stock material or miscellaneous articles
    • Y10T428/249921—Web or sheet containing structurally defined element or component
    • Y10T428/249953—Composite having voids in a component [e.g., porous, cellular, etc.]
    • Y10T428/249967—Inorganic matrix in void-containing component
    • Y10T428/249969—Of silicon-containing material [e.g., glass, etc.]

Definitions

  • the invention relates to endoprosthetic components.
  • the invention relates to endoprosthetic components which can be used as spinal implants.
  • Endoprosthetic components in particular for the fusion of vertebral bodies, are known. They are adapted in geometry to the anatomy of the human vertebral body, are located between two vertebral bodies and replace the intervertebral disc completely or partially.
  • Known components for fusing vertebral bodies are based, for example, on metallic materials, such as e.g. Tantalum or titanium.
  • PE polyethylene
  • PEEK polyethylene ether ketone
  • Ceramic components based on silicon nitride for example.
  • this class of materials has been developed with a view to achieving excellent high-temperature properties - for example, mechanical machining of metallic components for the automotive industry - and tends to be in the midfield for the properties required for this application such as strength, hardness and long-term stability compared to other ceramic high-performance materials based on oxide systems ,
  • a very important aspect of using ceramic components for fusion of vertebral bodies is the generally high rigidity of these materials, which is much higher than that of the human vertebral bodies.
  • stress shielding which can lead to the degradation of bone material and at least reduce or even prevent the build-up of new bone material.
  • Known ceramic cages are usually designed annular or adapted to the shape of human vertebral bodies, the ring consists of a monolithic, ie dense, solid and very rigid ceramic. In the center, these cages often have a cavity which is either filled with known bone substitute materials (autologous or allogenic) or has an artificial, porous, osseoinductive or osseoconductive structure, which is usually much less rigid than the outer ring. In this area, the bone cells are supposed to build up new bone material, whereby the cells involved need a corresponding mechanical stimulus.
  • the bone structure of a vertebral body is different, for example, the outer cortical bone substance is much denser and stronger than the internal spongious bone substance.
  • the bone structure of a person depends on his age and of course also individually different. Depending on the weight and activity of the person, different biomechanical loads act on the spine. As a result, it can lead to uncontrolled sinking of the components in the vertebral bodies, which can have a variety of complications and consequences.
  • the object of the invention is to provide an endoprosthetic component which is particularly suitable for the fusion of vertebral bodies and avoids or at least reduces the effect of "stress shielding".
  • An endoprosthetic component according to the invention comprises a first region and a second region, wherein the material of the first region has a greater strength than the material of the second region.
  • the first area is adapted to penetrate controlled in adjacent bone material in the implanted state.
  • the endoprosthetic component is a spinal implant, in particular a cage.
  • the use of such an endoprosthetic component is preferred as a spinal implant, in particular as a cage.
  • this can be achieved by providing at least a portion of a surface of the first region over a surface of the second region protrudes.
  • the portion of the first region projecting beyond the surface of the second region can then be designed such that it can penetrate in a controlled manner into the adjacent vertebral bodies.
  • One possible embodiment could be spikes or spikes that protrude beyond the surface of the second region and, when implanted, drill into the surface of the adjacent vertebral body. Over the length and the diameter of the spikes a maximum penetration depth can be defined, so that the penetration is controlled.
  • the first outer region of the component encloses the second inner region partially or completely.
  • the first region is preferably made of densely sintered, monolithic ceramic. This means that the first region is essentially non-porous, that is to say preferably a porosity of less than 5% by volume, more preferably a porosity of less than 3% by volume and particularly preferably a porosity of less than 1% by volume.
  • the material used is preferably oxidic material classes, such as e.g. the class of aluminas or zirconium oxides or any mixtures thereof.
  • the aluminas also comprise, according to the invention, zirconia-reinforced materials such as e.g. ZTA materials (zirconia thoughened alumina);
  • zirconium oxides include all types of tetragonal stabilized or partially stabilized zirconia oxides, e.g. Yttrium-, cerium- or gadolinium-stabilized zirconium oxides.
  • zirconia-based composites with alumina-containing components for reinforcement are conceivable, so-called ATZ materials.
  • the standard measured 4-point bending strengths of these materials are in the range between approx. 500 to approx. 2000 MPa.
  • the second inner region consists of a porous ceramic, which in principle is the same or a similar material as that of the first region can act, but does not have to.
  • the material of the inner first and / or the outer second region may be bioactivated by additional additions of bioactive substances.
  • bioactive substances may also be arranged in the pores of the second region.
  • HA Hydroxylapatite
  • TCP tricalcium phosphate
  • Glass-like substances such as bioglasses are also particularly suitable.
  • a bioglass comprising as main constituents SiO 2 (silica), CaO (calcium oxide), Na 2 O (sodium peroxide) and P 2 O 5 (phosphorus pentoxide) is used.
  • Biofunctionalization in the sense of promoting and stimulating bone growth, may also utilize any type of coating that utilizes the biomimetic approach, thus providing optimal conditions for osteogenesis to the cells involved in bone formation.
  • These may be nanostructured HA coatings or covalently bonded phosphating layers.
  • first and / or second portions of the endoprosthetic component may be made of other than the enumerated ceramics, particularly silicon nitride or any other materials, eg, plastics such as PE, PEEK or tissue-compatible metals such as titanium. as long as these materials meet the stated requirements.
  • the inner structure of the second inner region has a decisive influence on the osseoconductivity of the component, ie on the ability to build new bone material.
  • Porous, trabecular structures are particularly suitable for stimulating new bone formation. These structures are very similar to the structure of cancellous bone and provide optimal conditions for the growth of cells involved in bone formation.
  • the mechanical properties of the second inner region depend very much on the material composition and the structure. However, this also means that the selection of the material and the design of the structures allows the mechanical properties of the inner area to be tailored and adapted to the biological environment in which they are to be incorporated.
  • the second, trabecular region of the component is less firm and less rigid than the first, outer region of the component.
  • the first rigid region is provided in the interior of the component, for example as a pillar, and the second tabular region is arranged around this pillar.
  • Compressive strengths for such trabecular ceramic structures are typically in the range of 5 to 10 MPa. By using suitable manufacturing methods, however, compressive strengths up to the upper two-digit megapascal range can be achieved. The corresponding stiffnesses depending on the geometry are in the range of 5 to 50 GPa.
  • Decisive for the component according to the invention is the combination of these two areas or the design of the component resulting from the combination.
  • the first outer area is too massive, then due to the high rigidity of the monolithic ceramic material, the effect of the already described "stress shielding" arises. As a result, the component loses its total fusion function. The second, inner area is shielded from the load and due to the lack of mechanical stimulation no bone buildup occurs.
  • a solid outer region allows a large contact surface of the mechanically loadable first region of the component on the vertebral bodies, which counteracts sinking of the component.
  • the component can sink uncontrollably into the adjacent vertebral bodies.
  • a small wall thickness of the first outer area can also lead to an overall low mechanical stability of the component, so that the risk of breakage of the component, in particular during the fusion phase exists.
  • the bearing surface of the first region is reduced to such an extent that the strength of the component is still sufficiently high to increase the mechanical stability of the component as a whole guarantee.
  • the structural rigidity of the component decreases overall and approaches that of a vertebral body. This reduces the risk of stress shielding.
  • Typical wall thicknesses for the first area are in the range of a few millimeters, depending on whether it is a component for the lumbar or cervical area. Typical values for cervical components are between 2 and 3 mm, for lumbar components between 4 and 6 mm.
  • the first region on the bearing surfaces structures such as a circumferential tip or spikes, which allow a defined penetration of the component in the vertebral bodies and favor.
  • the structures of the first region penetrate into the vertebral bodies until the porous second region rests flat on the two adjoining vertebrae.
  • a preferred embodiment of the invention provides that the first region is adapted to penetrate so deeply into the adjacent bone material that at least a part of the surface of the second region is in contact with the bone material, so that a force transmission between the bone material and the surface the second area takes place.
  • This embodiment has the advantage that, for design reasons, it can not lead to a force shielding of the second region and therefore optimal conditions for the stimulation of the bone structure in this region are created.
  • FIG. 2a shows a conventional spine cage, between two vertebrae 1 and 2 is arranged.
  • the first outer region 3 is annular and encloses the second inner region 4.
  • the inner region 4 has a lower height than the outer ring 3 and thus does not come into contact with the surfaces of the adjacent vertebrae. With such a design, the described "stress shielding" occurs.
  • FIG. 2b shows a possible embodiment of the invention.
  • the first outer region consists of a monolithic ceramic ring 13, which encloses a porous ceramic filling, the second inner region 14.
  • the ceramic ring 13 is made significantly less strong and protrudes beyond the second inner portion 14 above and below.
  • the upper and lower edges 15 of the ceramic ring 13 are tapered so that these areas can easily penetrate into the surfaces 16 of the adjacent vertebral bodies 11 and 12.
  • other elements that allow penetration such as isolated tips, are also possible. It is essential that the penetration takes place in a controlled manner. In the in Fig. 2b shown embodiment, this is ensured by on the one hand only the parts which are provided for the penetration, can penetrate.
  • the maximum penetration depth is limited by the porous filling of the inner second region.
  • this design ensures that the second inner region comes into contact with the surfaces of the adjacent vertebral bodies and exerts mechanical stimulation on them. This effectively minimizes the dangers of stress shielding and uncontrolled sinking into adjacent vertebral bones.
  • Another preferred feature relates to the connection of the first area to the second area.
  • FIG. 3a shows the force curve in the cross section of a cage with a fixed connection between the first and the second area. The curve is steady.
  • FIG. 3b shows the force curve in the cross section of a cage with a movable connection. The curve is unsteady.
  • the trabecular second region can be ideally adapted to the stiffness of the vertebral body due to its structure and material composition.
  • the micromechanical movements and thus the mechanical stimulus for the formation of new bone can be set optimally and independently of the first area, which ensures the mechanical stability and the primary stability. Therefore, a particularly preferred embodiment provides that the first area is movably connected to the second area.
  • the design of the movable connection in detail is open. It is crucial that the trabecular second region after implantation rests flat on the adjacent vertebral bodies and defines the first monolithic region and can penetrate evenly into the vertebral bodies.
  • FIG. 4 shows a possible embodiment in which the annular or square outer first region 13 is movably connected to the inner second region 14.
  • the porous filling of the second region is held movably in the monolithic ring of the first region 13.

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical & Material Sciences (AREA)
  • Biomedical Technology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Transplantation (AREA)
  • Public Health (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Neurology (AREA)
  • Ceramic Engineering (AREA)
  • Medicinal Chemistry (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Dermatology (AREA)
  • Epidemiology (AREA)
  • Inorganic Chemistry (AREA)
  • Materials Engineering (AREA)
  • Structural Engineering (AREA)
  • Organic Chemistry (AREA)
  • Manufacturing & Machinery (AREA)
  • Dispersion Chemistry (AREA)
  • Molecular Biology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Composite Materials (AREA)
  • Prostheses (AREA)
  • Materials For Medical Uses (AREA)
  • Surgical Instruments (AREA)

Claims (13)

  1. Composant endoprothétique, le composant comprenant une première région externe (13) et une seconde région interne (14), le matériau de la première région (13) présentant une résistance supérieure à celle du matériau de la seconde région (14), la première région externe du composant entourant partiellement la seconde région interne, la première région (13) étant conçue pour, à l'état implanté, pénétrer de manière contrôlée dans un matériau osseux (11, 12) adjacent, caractérisé en ce que la seconde région (14) comportant des pores dont les tailles sont comprises entre 100 et 1000 µm, la porosité de la seconde région (14) étant interconnectée, et au moins une partie de la surface de la première région (13) faisant saillie au-delà de la surface de la seconde région (14).
  2. Composant endoprothétique selon la revendication 1, caractérisé en ce que la première région (13) est conçue pour pénétrer si profondément dans le matériau osseux (11, 12) adjacent qu'au moins une partie de la surface de la seconde région (14) est en contact avec le matériau osseux (11, 12), de sorte qu'une transmission de force se produise entre le matériau osseux (11, 12) et la surface de la seconde région (14).
  3. Composant endoprothétique selon l'une des revendications précédentes, caractérisé en ce que la première région (13) est reliée de manière mobile à la seconde région (14).
  4. Composant endoprothétique selon l'une des revendications précédentes, caractérisé en ce que la première région (13) n'est pas poreuse, c'est-à-dire qu'elle présente de préférence une porosité inférieure à 5 % en volume.
  5. Composant endoprothétique selon l'une des revendications précédentes, caractérisé en ce que la seconde région (14) est poreuse, la porosité étant comprise entre 75 et 85 % en volume.
  6. Composant endoprothétique selon la revendication précédente, caractérisé en ce que la seconde région (14) présente des pores dont la taille est comprise entre 400 et 600 µm.
  7. Composant endoprothétique selon l'une des revendications précédentes, caractérisé en ce que la première et/ou la seconde région (13, 14) comprend un matériau céramique.
  8. Composant endoprothétique selon l'une des revendications précédentes, caractérisé en ce que la première et/ou la seconde région (13, 14) comprend des substances bioactives.
  9. Composant endoprothétique selon la revendication 8, caractérisé en ce que les substances bioactives sont mélangées à un matériau à partir duquel la première et/ou la seconde région (13, 14) est formée, ou en ce que les substances bioactives sont présentes dans le matériau en couches ou régions.
  10. Composant endoprothétique selon la revendication 8, caractérisé en ce que la première et/ou la seconde région (13, 14) est revêtue de la substance bioactive au moins par régions.
  11. Composant endoprothétique selon la revendication 8, caractérisé en ce que les substances bioactives sont disposées dans les pores de la seconde région (14).
  12. Composant endoprothétique selon l'une des revendications 8 à 11, caractérisé en ce que la substance bioactive comprend de l'hydroxyapatite (HA) ou du phosphate tricalcique (TCP) ou du bioverre, en particulier un bioverre qui a comme constituants principaux SiO2 (dioxyde de silicium), CaO (oxyde de calcium), Na2O (hyperoxyde de sodium) et P2O5 (pentoxyde de phosphore).
  13. Composant endoprothétique selon l'une des revendications précédentes, caractérisé en ce que le composant est un implant pour colonne vertébrale.
EP13795250.3A 2012-11-26 2013-11-25 Élément endoprothétique Active EP2925258B1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102012221523 2012-11-26
PCT/EP2013/074576 WO2014080008A2 (fr) 2012-11-26 2013-11-25 Élément endoprothétique

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US (1) US10130734B2 (fr)
EP (1) EP2925258B1 (fr)
CA (1) CA2893279A1 (fr)
DE (1) DE102013224011A1 (fr)
WO (1) WO2014080008A2 (fr)

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CN107072795A (zh) * 2014-07-22 2017-08-18 陶瓷技术有限责任公司 用于融合椎体的部件
US20200061238A1 (en) * 2017-03-28 2020-02-27 Ceramtec Gmbh Ceramic Sliding Bearing
CN108689699A (zh) * 2018-06-14 2018-10-23 长沙鹏登生物陶瓷有限公司 一种高柔韧性人工骨骼关节用陶瓷复合材料及制备方法
GB2585397B (en) * 2019-11-28 2021-09-01 Matortho Ltd Ceramic monobloc femoral component, kit and system comprising the same, and method of manufacture and use thereof

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US6013591A (en) * 1997-01-16 2000-01-11 Massachusetts Institute Of Technology Nanocrystalline apatites and composites, prostheses incorporating them, and method for their production
US6979353B2 (en) 2001-12-03 2005-12-27 Howmedica Osteonics Corp. Apparatus for fusing adjacent bone structures
WO2009076278A1 (fr) 2007-12-12 2009-06-18 Intelligent Implant Systems Dispositif de fusion inter-corps et de partage de charge
US8765163B2 (en) * 2008-07-10 2014-07-01 The University Of Sydney Biocompatible material and uses thereof
US20100042216A1 (en) 2008-08-15 2010-02-18 Pioneer Surgical Technology, Inc. Implant for Deploying Bone Graft Material and Methods Thereof
US20110012280A1 (en) 2009-07-14 2011-01-20 Doctors Research Group, Inc. Method for fabricating a multi-density polymeric interbody spacer
WO2012063865A1 (fr) * 2010-11-10 2012-05-18 Hoya株式会社 Ecarteur vertébral

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EP2925258A2 (fr) 2015-10-07
WO2014080008A3 (fr) 2015-04-16
US20150335782A1 (en) 2015-11-26
US10130734B2 (en) 2018-11-20
DE102013224011A1 (de) 2014-05-28
CA2893279A1 (fr) 2014-05-30
WO2014080008A2 (fr) 2014-05-30

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